Transcatheter Aortic ValveImplantation (TAVI), Central/Eastern Europe, Middle East & Africa. Object Status Conditional 8. Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement* 1 so you get greater control when it matters most. Radiopaque gold markers provide a reference for deployment depth and commissure location. Your dentist and all doctors need to know about your Medtronic TAVR valve. Benefits of a large EOA may include: Supra-annular valve design maximizes leaflet coaptation and promotes single-digit gradients and large EOAs. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. Find more detailed TAVRinformation, educationalresources, and tools. General surgical risks applicable to transcatheter aortic valve implantation: abnormal lab values (including electrolyte imbalance, allergic reaction to antiplatelet agents, contrast medium, or anesthesia, exposure to radiation through fluoroscopy and angiography. November 2016;18(11):67. Update my browser now. The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. Prior to the procedure, measure the patients creatinine level. Treatments & Therapies Re-engineered delivery system expands flexibility for360 range of motion and increases conformability to the anatomy for a 50% reduction in tracking forces*1 in challenging anatomies. You may also call 800-961-9055for a copy of a manual. cy[7Ju)z|~{B3% ^!pE~(u|@x9;D9DYY(bC4|fffn\W4Lr[QFX Fewer instances of prosthesis-patient mismatch (PPM), which has been correlated to improved long-term survival, A large EOA provides improved flow, less resistance, and better long-term durability. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. Update my browser now. Transcatheter Aortic Heart Valves Lowest delivery profile These are the hallmarks of a successful TAVRprocedure and the inspiration for the Evolut FXtranscatheter aortic valve system. Healthcare Professionals 2010; 121:2123-2129. Curr Treat Options Cardiovasc Med. Medtronic, www.medtronic.com. Medtronic, www.medtronic.com Object Category Heart Valves and Annuloplasty Rings. Brand Name: Evolut PRO+ Version or Model: EVPROPLUS-29US Commercial Distribution Status: In Commercial Distribution Catalog Number: Company Name: MEDTRONIC COREVALVE LLC Primary DI Number: 00763000211127 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 079527231 * Terms of Use Damage may result from forceful handling of the catheter. Healthcare Professionals EVOLUT PRO SYSTEM Transcatheter Aortic Valve Replacement (TAVR) The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Evolut FX PRODUCT DETAILS EXCEPTIONAL DESIGN TAVR risks may include, but are not limited to, death, stroke, damage to the arteries, bleeding, and need for permanent pacemaker. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in the following patient populations: Patients who do not meet the criteria for symptomatic severe native aortic stenosis as defined: (1) symptomatic severe high-gradient aortic stenosis aortic valve area 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient 40mmHg, or a peak aortic-jet velocity 4.0m/s; (2) symptomatic severe low-flow, low-gradient aortic stenosis aortic valve area 1.0cm2 or aortic valve area index 0.6cm2/m2, a mean aortic valve gradient <40mmHg, and a peak aortic-jet velocity <4.0m/s; with untreated, clinically significant coronary artery disease requiring revascularization; with a preexisting prosthetic heart valve with a rigid support structure in either the mitral or pulmonic position if either the preexisting prosthetic heart valve could affect the implantation or function of the bioprosthesis or the implantation of the bioprosthesis could affect the function of the preexisting prosthetic heart valve; patients with liver failure (Child-Pugh Class C); with cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support; patients who are pregnant or breastfeeding. Implanting a CoreValve Evolut R, Evolut PRO+, or Evolut FX bioprosthesis in a degenerated surgical bioprosthetic valve (transcatheter aortic valve in surgical aortic valve [TAV-in-SAV]) should be avoided in the following conditions: The degenerated surgical bioprosthetic valve presents with: a significant concomitant paravalvular leak (between the prosthesis and the native annulus), is not securely fixed in the native annulus, or is not structurally intact (e.g., wire form frame fracture); partially detached leaflet that in the aortic position may obstruct a coronary ostium; stent frame with a manufacturer-labeled inner diameter < 17 mm. The Evolut PRO+ system offers the lowest delivery profile for 2329 mm valves, excellent hemodynamics, the broadest annulus range,* and advanced sealingwith an external tissue wrap on all valve sizes. The CoreValve Evolut R, Evolut PRO+, and Evolut FX Systems are contraindicated in patients who cannot tolerate Nitinol (titanium or nickel), gold (for Evolut FX Systems alone), an anticoagulation/antiplatelet regimen, or who have active bacterial endocarditis or other active infections. The external wrap increases surface contact with native anatomy, providing advanced sealing. Important Safety Information. Not doing so could result in injury or death. Pibarot P, Dumesnil JG. United States of America * Country / Region. This site is Exclusively Sponsored by BRACCO, Orthopedic Implants, Materials, and Devices. Follow us on Twitter @MDT_StructHeart and subscribe for email updates about TAVR innovations. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Cardiovascular Cardiovascular Access instructions for use and other technical manuals in the Medtronic Manual Library. Medtronic MRI Resource Library: Home This library contains technical information on whether an MRI scan can be performed and how to perform a scan on patients with Medtronic implantable devices. The Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe. Access instructions for use and other technical manuals in the Medtronic Manual Library. Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut Pro System: Generic Name: aortic valve, prosthesis, percutaneously delivered . May 2008;94(5):637-641. van Slooten YJ, van Melle JP, Freling HG, et al. PRODUCT DETAILS EXCEPTIONAL DESIGN See the CoreValve Evolut R, the CoreValve Evolut PRO and the Evolut PRO+ device manuals for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. Bench testing may not be indicative of clinical performance. October 14, 2020 Medtronic announced it is starting a randomized, head-to-head study comparing two transcatheter aortic valve replacement (TAVR) systems in patients with severe symptomatic aortic stenosis (ssAS). Search by the product name (e.g., Evolut) or model number. Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Transcatheter Aortic Valve Replacement (TAVR), Central/Eastern Europe, Middle East & Africa. Manuals can be viewed using a current version of any major internet browser. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations. If you continue, you may go to a site run by someone else. With an abnormal growth in the heart or arteries, Whose failing valve is too small or too big, Whose arteries are too small for the device, Whose arteries that deliver blood to the heart maybe blockedby the device, Whose arteries that deliver blood to the heart need tobe treated, Whose arteries that deliver blood to the brain need tobe treated, Who have a reaction to some imaging solutions, cannot take medications that reduce the risk of blood clots, or who have a reaction to somemetals, Who have severe problems with bleeding or bloodclotting, Who have specific types of surgical valves implanted in the pulmonaryvalve, Who have specific types of surgical valves implanted in the mitralvalve, Who have thick heart muscles, making it difficult for the heart to pumpblood, Who have thick heart muscles that block the heart from pumpingblood, Who need to have a surgical procedure on theiraorta. Up to 80% deployment. The SMall Annuli Randomized To Evolut or Sapien (SMART) post-market trial will compare valve safety and performance of the self-expanding Medtronic CoreValve Evolut Pro and Pro . This study is a prospective, single arm, multi-center . You can search the Medtronic MRI Resource Library for MRI guidelines and technical information by model number or product name. - (00:40), Watch this brief video comparing deployment stability from Evolut PRO+ to Evolut FX transcatheter aortic valves. Heart. Evolut FX. More information (see more) AHK 7700, Model 7700 heart valve Medtronic, www.medtronic.com. endstream endobj startxref Optimized stability layer increases catheter support during deployment and provides 50% less ventricular movement*1 so you get greater control when it matters most. With an updated browser, you will have a better Medtronic website experience. With an updated browser, you will have a better Medtronic website experience. Products Update my browser now. Follow all care instructions to ensure the best possible results. X'AD`4.$ 2 Transcatheter Aortic Heart Valves These legacy and new design features provide the following sealing mechanisms: The Evolut TAVI platform demonstrates EOAs that are consistently large and may have a benefit for healthier, more active patients. Evolut PRO. Your use of the other site is subject to the terms of use and privacy statement on that site. Transcatheter Aortic Heart Valves Cardiovascular Update my browser now. Dysfunctions of a Medtronic TAVR valve,including but not limited to: Valve frame does not open (expand) allthe way, Pannus the formation of scar tissuethat may cover or block the valve fromfunctioning normally, Wear, tear, or movement forward (prolapse)or backward (retraction) from the normalposition of the valve leaflets, A break in the stitches (sutures) of the valveframe or leaflets, Leakage through or around the valve orvalve frame, Incorrect position of the valve, either toohigh or too low, Regurgitation backward flow of bloodthrough the valve, Stenosis narrowing of the opening ofthe valve, Valve migration upward or downwardmovement of the device from where itwasoriginally placed, Embolism an abnormal particle (air, bloodclots) floating in the blood stream or attachedto an object, including the valve or deliverysystem component, Infection of the heart, blood, or other areas, Thrombosis (including valve thrombosis) blood clot, including a blood clot on the valve, Individual or multi-organ insufficiency or failure. Find important safety information about the Medtronic transcatheter aortic valve and TAVR procedure. (v-C/Hi)1LvJsRLvfbt]'#B8-%ED'Xk/744 E6dtt40tt0i6G Jq@5, l@ !W Recapture and reposition The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. The Evolut FX transcatheter aortic valve system sets new expectations for precision, control, and predictability in TAVR procedures. 2020 Medtronic. Evolut FX TAVR/TAVI Deployment Video Broadest annulus range based on CT derived diameters. In addition, you may experience otherproblems that have notbeen previouslyobservedwith this procedure. This procedure should only be performed where emergency aortic valve surgery can be performed promptly. 2020 Medtronic. Update my browser now. Healthcare Professionals The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO device is Medtronic CoreValve Evolut PRO System, and the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System. All rights reserved, Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. 4544 0 obj <> endobj Its self-expanding nitinol frame enhances the ability to conform and seal to the native annulus. During the procedure, monitor contrast media usage. Indications, Safety, and Warnings Product Details The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Heart Valves and Annuloplasty Rings More. We are here for you. It is possible that some of the products on the other site are not approved in your region or country. performance of the Evolut platform over time. Indications, Safety, & Warnings. Less information (see less). Home AND DISABLING STROKES AT 30 DAYS3, Evolut Pro+ Experience The delivery system features a 1:1 response, thus providing immediate feedback between the deployment knob and the movement of the capsule. The safety and effectiveness of the bioprostheses for aortic valve replacement have not been evaluated in patient populations presenting with the following: Blood dyscrasias as defined as leukopenia (WBC <1,000cells/mm3), thrombocytopenia (platelet count <50,000cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states; congenital unicuspid valve; mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation [3-4+]); moderate to severe (3-4+) or severe (4+) mitral or severe (4+) tricuspid regurgitation; hypertrophic obstructive cardiomyopathy; new or untreated echocardiographic evidence of intracardiac mass, thrombus, or vegetation; native aortic annulus size <18mm or >30mm per the baseline diagnostic imaging or surgical bioprosthetic aortic annulus size <17 mm or >30 mm; transarterial access unable to accommodate an 18Fr introducer sheath or the 14Fr equivalent EnVeo InLine Sheath when using models ENVEOR-US/D-EVPROP2329US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-2329 or transarterial access unable to accommodate a 20Fr introducer sheath or the 16Fr equivalent EnVeo InLine Sheath when using model ENVEOR-N-US or transarterial access unable to accommodate a 22Fr introducer sheath or the 18Fr equivalent Evolut PRO+ InLine Sheath when using model D-EVPROP34US or Evolut FX Delivery Catheter System with InLine Sheath when using model D-EVOLUTFX-34; prohibitive left ventricular outflow tract calcification; sinus of Valsalva anatomy that would prevent adequate coronary perfusion; significant aortopathy requiring ascending aortic replacement; moderate to severe mitral stenosis; severe ventricular dysfunction with left ventricular ejection fraction (LVEF) <20%; symptomatic carotid or vertebral artery disease; and severe basal septal hypertrophy with an outflow gradient. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, for transcatheter aortic valve replacement (TAVR). $/R$J101 2017 Dec;6 (2):183-192. doi: 10.1007/s40119-017-0100-z. Fluoroscopic procedures are associated with the risk of radiation damage to the skin, which may be painful, disfiguring, and long-term. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Update my browser now. * Third party brands are trademarks of their respective owners. The supra-annular leaflet position keeps the working portion of the valve above and unconstrained by the native annulus. Search by the product name (e.g., Evolut) or model number. Broadest annulus range* You may also call800-961-9055 for a copy of a manual. per pulse sequence) in 1.5-Tesla and 3-Tesla MR systems, using an MR system reported, whole body averaged SAR of 2-W/kg or less, as follows: Highest temperature changes For applicable products, consult instructions for use on manuals.medtronic.com. Refer to the Instructions for Use for available sizes. The supra-annular, self-expanding design of the Evolut PRO system provides a large effective orifice area (EOA). Home The commercial name of the Evolut R device is Medtronic CoreValve Evolut R System, the commercial name of the Evolut PRO+ device is Medtronic Evolut PRO+ System, and the commercial name of the Evolut FX device is Medtronic Evolut System. The Evolut PRO+ TAVI System includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest annular range (for self-expanding TAVI technology) on the market. More patients have access to the minimally invasive TAVI procedure because of the expanded annulus range. Keep appointments with your doctor. The Evolut PRO system combines exceptional valve design and advanced sealing with an excellent safety profile. Update my browser now. Products See how the external tissue wrap on the Evolut PRO TAV performs. * Third party brands are trademarks of their respective owners. Safety Topic / Subject Heart Valves and Annuloplasty Rings. - (13:30), Discussion with Dr. Didiert Tchetche and Dr. Gilbert Tang The EnVeo PRO system retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus. 4588 0 obj <>stream More information (see more) Smooth, controlled, precise, and predictable. Healthcare Professionals including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. Evolut FX system enhancements make TAVR procedureseasier to visualize and more predictable. For best results, use Adobe Acrobat Reader with the browser. Access instructions for use and other technical manuals in the Medtronic Manual Library. MRI Resources For clinicians whose patients have a Medtronic system VIEW MRI TECHNICAL MANUALS (opens new window) MRI INFORMATION BY DEVICE TYPE Cardiac Monitors Deep Brain Stimulation Systems Implantable Cardiac Devices Neurological Shunts Spinal Cord Stimulation Systems MRI GUIDELINES AND MANUALS The Evolut PRO+ system is indicated to treat annulus ranges up to 30 mm in diameter and hasthe ability to treat the broadest annulus range* of any commercially available TAVR system. The EnVeo PRO system retains its outer diameter as it enters the vessel and remains at this diameter as it is advanced to the annulus. AMEND Mitral Annuloplasty Ring, All Sizes Valcare Medical LTD., www.valcaremedical.com. If you continue, you may go to a site run by someone else. Broadest annulus range based on CT derived diameters. Your use of the other site is subject to the terms of use and privacy statement on that site. Home August 2006;92(8);1022-1029. All other brands are trademarks of a Medtronic company. Pibarot P, Dumesnil JG, Jobin J, Cartier P, Honos G, Durand LG. Products For transfemoral access, use caution in patients who present with multiplanar curvature of the aorta, acute angulation of the aortic arch, an ascending aortic aneurysm, or severe calcification in the aorta and/or vasculature.